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Completed

NCT Number: NCT03655314

Using the Electronic Health Record to Guide Management of Newborn Weight Loss

Weight loss is normal for healthy newborns in the first few days, especially for those exclusively breastfed, who may have low enteral intake for several days. Although most newborns tolerate this early period of weight loss well, those with pronounced weight loss become at increased risk of feeding problems and hyperbilirubinemia, which are the two most common causes of neonatal readmission. To facilitate the assessment of risk for an individual newborn, the Newborn Weight Tool (NEWT) has been developed to categorize each infant's weight loss according to population norms, so that formula can be administered when weight loss is pronounced and avoided when weight loss is normal. The Healthy Start study will be a randomized, controlled trial testing whether displaying NEWT to clinicians providing newborn care can improve neonatal health outcomes including formula use, weight loss and readmission. Newborns will be randomly assigned either to display weight with NEWT weight categorization to their providers in the electronic health record (EHR) or to usual care (weight displayed without NEWT categorization).

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Key information

Conditions

Breastfeeding Behavior Bottle Feeding Breast Feeding Breastfeeding, Exclusive Feeding Behavior Feeding, Bottle Morbidity;Perinatal

Age range

6 hour–96 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco Medical Center

San Francisco, California, 94122, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Assignment to a bed assignment on the well newborn service at the time of the first weight measured subsequent to birth weight and at >6 hours and <=96 hours of age

Exclusion criteria

  • None

Treatment and study plan

NEWT

Other

The Newborn Weight Tool (NEWT) is publicly available at www.newbornweight.org. For this intervention, NEWT will be embedded into the electronic medical record along with a flag for weight loss greater than or equal to the 75th centile of birth weight.

Other names: Newborn Weight Tool

Usual Care

Other

The electronic medical record will display the weight only as weight in grams and percent weight lost from birth weight.

Primary outcomes

  1. Concordance with feeding recommendation during the birth hospitalization

    Time frame: 0-96 hours

    Feeding is defined as concordant with feeding recommendation if any of the following occur: 1) for newborns who do not have documented weight loss >=75th NEWT centile, formula is not used; 2) for newborns with only one weight documented that is more pronounced than the 75th centile, no formula is used prior to the weight documented at more pronounced than the 75th centile; 3) for newborns who have two weights documented more pronounced than the 75th centile, formula is used.

Secondary outcomes

  1. Proportion readmitted to the hospital

    Time frame: 0-30 days

    Readmission to the hospital after discharge from the birth hospitalization

  2. Length of hospital stay

    Time frame: 0-96 hours

    Length of stay during the birth hospitalization

  3. Proportion exclusively breastfed

    Time frame: 0-96 hours

    Feeding only breast milk without any other fluid or food other than vitamins, minerals and medications

  4. Proportion with donor milk use

    Time frame: 0-96 hours

    Use of banked donor milk

  5. Excess neonatal outpatient utilization

    Time frame: 0-30 days

    >3 outpatient visits in the first 30 days (newborns may have up to 3 preventive outpatient visits in the first 30 days)

  6. Ratio of indicated formula use to non-indicated formula use during the birth hospitalization

    Time frame: 0-30 days

    Ratio of formula used either for hypoglycemia or for weight loss >=75th centile to formula used for in the absence of these

  7. Non-preventive outpatient utilization

    Time frame: 0-30 days

    Number of non-preventive outpatient visits

  8. Outpatient utilization

    Time frame: 0-30 days

    Number of outpatient visits

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Beginning With a Healthy Start: A Randomized Controlled Trial of Informatics-Enhanced Newborn Weight Management

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 31, 2018
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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